Breakthroughs Blog: WHO

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. On Friday, February 15, President Trump signed into law a spending bill covering funding for State & Foreign Operations (SFOPs) for fiscal year (FY) 2019. The bill provides US$8.8 billion to the overall Global Health Programs account at the State Department and US Agency for International Development (USAID), which is a $150 million increase from the FY18 enacted level and $2.1 billion above the President’s FY19 request. Funding for all global health programs at the State Department and USAID either increased or remained flat compared to the FY18 enacted level and were also well above the President’s budget request. The World Health Organization (WHO) is working to contain an unprecedented outbreak of Lassa fever in West Africa, which has killed 59 people in recent weeks. This Ebola-like virus is transmitted to humans via exposure to contaminated rate urine and droppings, as well as from person-to-person. Although Lassa fever is endemic in parts of West Africa with outbreaks occurring yearly, health officials have confirmed at least 275 cases in Nigeria—the epicenter of the outbreak—since the beginning of the year. WHO has expressed concern regarding the high number of cases so early in the Lassa fever season, which is due to last another four months. Controlling Lassa fever is a challenge because its symptoms can be vague, such as headaches and chest pain, making the disease difficult to diagnose, and there is no licensed vaccine yet available. To contain the current outbreak, WHO is forming a regional coordination mechanism to share, process, and evaluate information regarding suspected cases and is also intensifying public awareness efforts about how to deter rats. In experimental studies conducted in mice, an antibiotic drug called AN12855 was shown to be more effective against tuberculosis (TB) than isoniazid, one of the standard treatments available. The new drug demonstrated both a much lower tendency to develop resistance, and it remained in the tissues where the bacteria that causes TB resides for longer, thus killing the bacteria more effectively. Further studies are required to determine if these outcomes will translate to improvements in treatments for humans. Current treatment for TB can range from six months to more than a year; thus, researchers are working to develop new drug regimens that shorten and simplify treatment.

A “who’s who” of politicians, philanthropists, CEOs, and civil society leaders descended upon New York City this week for the annual United Nations General Assembly (UNGA)—a gathering renowned for its policymaking, pledging, and perennial traffic problems. GHTC was on the scene all week—attending side events, tuning into the official debates, and navigating police barriers—to be your eyes and ears on the ground. Here is what we heard and our top four takeaways on global health research and development (R&D): 1. We can’t end TB without new tools, so it’s vital for world leaders to marshal the political will and resources to close the TB R&D funding gap. Tuberculosis (TB) was a top topic at this year’s assembly with the convening of the first high-level meeting (HLM) on TB. Repeatedly, we heard—from advocates and policymakers, at side events and in in the official proceedings—how poor treatment options are a cornerstone of our failure to eradicate TB and of growing drug resistance, and that new vaccines and improved treatments and diagnostics will be key to turning the tide. While much attention focused on this lack of necessary tools, equal attention focused on the lack of political will and resources to end the epidemic. Many speakers lamented how shamefully slow progress has been since the World Health Organization (WHO) declared TB a global emergency 25 years ago and highlighted the urgent need to close the funding gap for TB, including the US $1.3 billion gap for TB R&D.   As the curtain closed on the HLM, world leaders, as expected, endorsed a carefully negotiated political declaration. GHTC was pleased to see it include a commitment to increasing investment in TB R&D by $2 billion and strong recognition of the importance of cross-border, cross-sector collaboration in driving product development. However, we also share concerns raised by other advocates on accountability. For this meeting to catalyze true change, rhetoric must now translate to action, and commitments must be matched with mechanisms that track investments and hold nations accountable. 2. There are many roads on the path to universal health coverage, but innovation can be an accelerator. Universal health coverage (UHC) was another topic that took the spotlight at UNGA 73, championed by the issue’s top “cheerleader in chief” WHO Director-General Dr. Tedros Adhanon Ghebreyus, who has made achieving UHC a centerpiece of his directorship. Given the focus of the world’s doctor on UHC, many advocates at UNGA framed their specific issues through the lens of UHC, highlighting the myriad of steps needed to achieve this ambitious goal‒from building a stronger health workforce, to expanding access to medicines, to tackling leading killers like malaria, HIV and AIDS, and TB. Yet, a common theme heard across these conversations is that along each of these roads, innovation can be an accelerator.   Throughout the week, speakers highlighted how innovations and new technologies can help deliver care more efficiently and effectively, improve access and drive down costs, and accelerate countries along the path to achieving UHC. TB advocates highlighted how shorter treatment regimens can improve care, decrease costs, and free up resources, while digital health advocates argued that better use of data can empower health workers to track and treat patients and allocate precious health resources most effectively. Others highlighted how innovative new tools like point-of-care diagnostics can bring improved care to the community level and to people in the most remote corners of the globe. 3. We need additional resources for R&D, and that requires countries to step up in an equitable way. Domestic resource mobilization and equitable financing were words repeated throughout the week, particularly in conversations around the TB HLM and closing the TB R&D funding gap. Advocates, think tanks, and even government officials, argued that high-burden TB countries need to increase domestic investment in TB R&D and treatment. Some advocates have called for a “fair share” or equitable financing approach to TB R&D financing, with each country committing to spend .1 percent of their GDP on R&D. Others spoke to the potential of the BRICS nations—Brazil, Russia, India, China, and South Africa—to play a greater role in financing R&D.   While much of the TB financing dialogue focused on increasing public sector contributions, conversations also highlighted the impact and further potential of financing models like the airline-tax-funded work of UNITAID or public-private partnership approaches—like product development partnerships and the work of the Global Health Innovative Technology Fund—which have married multisector contributions to bring novel, affordable, accessible tools to market. Other speakers highlighted the opportunity for industry to increase its TB R&D investment, though many lamented that although industry has brought new TB drugs and diagnostics to market in recent years, uptake has been slow due to high product costs. 4. There is reason for optimism and reason for concern. The mood seemed mercurial in midtown Manhattan, as UNGA orators vacillated between optimism and concern about the future of global health and development. In the drumbeat to UNGA, the always-impatient optimists Bill and Melinda Gates unveiled their foundation’s Goalkeepers report. The report’s stylish line graphs, which show a downward trajectory on health issues like child mortality, are uplifting and inspiring—a great reminder of the staggering progress we’ve achieved in global health and what’s possible for the future.   The basis of our optimism about the world has always been our belief in the power of innovation to redefine what’s possible – Bill and Melinda Gates   Yet, three years in, it has also become clear the world is not on track to meet the Global Goals. And even the optimistic Gates are reminding us that though we hold the blueprint for a healthier world, continued progress is not inevitable. The choices our policymakers implement today will determine whether progress continues or stalls. Throughout the week, many speakers gave voice to fears, highlighting concerns that foreign aid spending is under increased attack in leading donors countries like the United States—a notion echoed in President Trump’s speech to the Assembly—and that political changes like Brexit and an “America First” doctrine signal a movement toward isolationism over collective action. Given significant global health R&D funding comes through foreign aid budgets and the necessity of collaborative global action to deliver the cures of tomorrow, these developments are worrisome. Will these trends threaten progress, or will momentum continue? That’s a question we’ll surely continue to reflect on for many UNGAs to come.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. The US government has launched its first national biodefense strategy to address naturally occurring threats, such as outbreaks of infectious diseases, alongside protections against bio-chemical weapons. The policy puts all aspects of US biodefense under one roof and establishes a Cabinet-level committee to coordinate activities. Provisions within the strategy also call for increased surveillance and research of potential global threats to prevent outbreaks from reaching American shores. Health security experts hope the release of this strategy will help to better prepare the United States to deal with such threats. For the fourth year in a row, tuberculosis (TB) remains the world’s top infectious killer—killing more than 1.6 million people annually, according to the World Health Organization’s (WHO) global TB report. The disease will receive increased political attention this week, as world leaders gather for the first-ever United Nations high-level meeting on TB. TB advocates hope the meeting will rally the global support and resources required to expedite progress. Debates between the United States and other countries regarding intellectual property had momentarily derailed negotiations on an accompanying political outcome declaration, but that is now expected to be endorsed on Thursday. The WHO TB report, which was released in advance of the meeting, also highlights a US $1.3 billion gap in funding for the research and development of new treatments to address the 3.6 million people suffering from TB who are not receiving treatment. The National Institute of Allergy and Infectious Diseases and the Duke University School of Medicine have begun enrollment for a Phase 1 trial of a new antimalarial drug, called DM1157, to test its efficacy in humans. DM1157 is a modified version of chloroquine, an antimalarial drug to which many strains of the most deadly form of malaria have grown resistant. This modified version of chloroquine interferes with the metabolism of the parasite and inhibits its ability to expel the drug. As the number of drug-resistant malaria cases grows, DM1157’s positive results during efficacy trials in animals provides hope for its efficacy in human cases.

The 71st World Health Assembly (WHA), held from May 21-26 in Geneva, featured all the expected verbal jousting over policy positions on key issues facing the World Health Organization (WHO) and the broader global health community, though the resolutions touching on research and development (R&D) ultimately passed by consensus. In particular, three items stood out.Access to medicinesAs anticipated, the debate on access to medicines featured some aggressive verbal sparring by member states, but in the end, all this talk produced only incremental action: Member states passed a resolution tasking the WHO secretariat with developing a roadmap to address access to medicines to be presented at next year’s WHA.Member states have long agreed on the importance of improving access to medicines, but have long struggled to achieve consensus on actions WHO should take in pursuit of this aim, despite many working groups and expert committees offering their own sets of recommendations. Countries used this WHA agenda item as another opportunity to pontificate on their disparate and entrenched views. The US representative was particularly bullish in her remarks this year, stating that senior WHO officials should focus on WHO’s core mandate rather than becoming “political activists” on topics like intellectual property (IP) and arguing that other countries are “free riding” on the health R&D investments of US taxpayers.Despite these verbal fireworks, it was clear that no country was willing to be the one to upset the carefully negotiated resolution language from the January Executive Board (EB) meeting calling for the WHO secretariat to establish this roadmap. As result, while strong language was the order of the day, the resolution passed unanimously without any textual changes. Per the resolution, WHO will now undertake a consultation process to develop a consensus work plan for consideration at next year’s EB and WHA. The team tasked with developing this plan has a tall order ahead of them, and it will remain to be seen whether they can forge a consensus path forward in an area where others before them have faltered. It is also unclear whether nongovernmental organizations in official relations with WHO will be included in the consultation process, but GHTC will continue to call for an appropriate role for civil society.Global Strategy and Plan of Action on Public Health, Innovation and Intellectual PropertyA close companion to the agenda item on access to medicines was WHA’s consideration of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA-IP), which is the current iteration of a more than decade-long process to define WHO’s role in governing IP within the United Nations system. Up for debate was whether WHO should implement a diverse range of recommendations put forward by a WHO expert review panel—recommendations that have received mixed support among different member states. Coming out of the EB meeting, board members had hammered out what they saw as a compromise resolution—the text called for WHO to implement items from the report that were already “consistent with WHO’s existing mandate and authorities” to ensure some steps would move forward, while essentially tabling the other recommendations which lacked consensus. Many wondered going into WHA whether this consensus would stand or whether member states would attempt to re-litigate the resolution text.Like the access agenda item, this debate also saw a lot of verbal jousting. Clashing comments from the United States and India provided—in microcosm—a view of the state of the debate on WHO’s mandate in IP. On one side, member states including India, Brazil, Colombia, and others argued for a robust and expansive embrace of the more far-reaching recommendations contained in the expert report. These include a call for a percentage of GDP spending target for R&D to support health in low- and middle-income countries, full implementation of the recommendations from the UN Secretary-General’s High-Level Panel on Access to Medicines, and the pursuit of mechanisms to move the global innovation ecosystem to delink pricing from R&D costs.On the other side, the United States and other countries argued for a more limited mandate for WHO and supported the compromise resolution text calling for WHO to only implement recommendations already aligned with its strategy and mandate. Under this view, WHO could proceed to implement those points on which there is clear consensus, effectively confining future activities to the scope of existing ones. On a more positive note, the US statement also called out strong support for WHO’s regulatory strengthening and harmonization activities and for strengthening R&D capacity globally overall.Despite the widely incongruent views of which direction WHO should take over the coming years, countries were not willing to take the risk of reopening the text of the resolution, fearing that they might very well have more to lose than they could possibly gain by re-litigating the text. As a result, WHO’s path forward in this space remains muddled and largely the status quo.Preparations for the High-Level Meeting on TuberculosisIn a refreshing change from the contentious debates on access and IP, the assembly also considered a number of documents and plans related to WHO’s input into preparations for the upcoming High-Level Meeting (HLM) on Tuberculosis (TB) in September. Of particular note, the draft multisectoral accountability framework cited, among example actions that should be taken, the “development and implementation of a global strategy for tuberculosis research and development, including the development and facilitation of international tuberculosis research networks.” While this language does not represent a concrete WHO commitment and no organization was identified as responsible for the strategy, it is still a positive acknowledgment of the need for R&D for TB technologies.In addition, in his remarks concluding the debate on TB, WHO Director-General Dr. Tedros Ghebreyesus made a strong statement of his support for R&D to address drug-resistant TB and antimicrobial resistance (AMR) more broadly. He noted that one cannot talk about AMR without talking about TB and vice versa, and that one cannot talk about TB nor AMR without talking about R&D. He then singled out cross-sector collaboration on R&D as being particularly important, remarking that “FENSA [the Framework of Engagement with Non-State Actors] is not meant to be a fence,” and that he hoped to bring the private sector to the table in an appropriate fashion. The ways in which Dr. Tedros’ desire to foster cross-sector collaboration manifests (or not) in the preparations for the HLM will be highly indicative of whether FENSA will actually serve to foster or conversely hinder collaboration moving forward.Key takeawaysUltimately, debate at this year’s WHA reinforced what many watching the global R&D ecosystem already knew; there is a fundamental tension over the very foundation of how global health R&D should be supported, and this tension was in no way resolved. On the one hand are proponents for moving toward delinkage and mechanisms to reshape incentives for R&D in ways that separate the costs of R&D from the sale price of products. On the other are those who argue that access is a much larger question than simply IP and trade laws and that focusing on those topics to the exclusion of other issues like regulatory barriers does a disservice to the dialogue. The one thing we can all agree on is that this dialogue will certainly continue, and GHTC will continue keeping you up to speed.